SIGNA Architect — Class II medical device recall Z-0518-2025
Ongoing recall by GE Medical Systems, LLC, reported 2024-12-04, distributed nationwide. Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, c
| Recall number | Z-0518-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2024-10-28 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, ES, IN, JP, KR, LV, MX, PL, RU, SA, TW |
| Quantity | 53 units |
| UPC / GTIN / UDI-DI | 00195278283481, 00840682122702, 00840682147095 |
Product
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Reason for recall
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0518-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.